Neuren Pharmaceuticals (ASX:NEU) announced financial results for the quarter ended 30 September 2022.
New Drug Application (NDA) for trofinetide to treat Rett syndrome accepted by the US Food and Drug Administration (FDA).
Subject to approval of the NDA, Neuren expects to receive revenue in 2023 for Rett syndrome in the US alone of A$112 million plus double-digit percentage royalties on net sales.
Discussions with potential partners for trofinetide ex-North America are continuing.
Commenced Phase 2 clinical trials of NNZ-2591 in Angelman, Phelan-McDermid and Pitt Hopkins syndromes.
Neuren promoted into the S&P/ASX 300 index.
Expertise in pediatric neurology and orphan drug development enhanced by appointment of Liza Squires M.D. as Chief Medical Officer.
A$27.3 million cash at 30 September 2022, with additional receipt of US$10 million in October ? well funded to execute NNZ-2591 Phase 2 trials and foundational work for Phase 3 across all indications, notwithstanding the anticipated material cash flows from trofinetide.
Following the announcement the company?s share price rose 1.256%.